← Product Code [JLJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLJ) · K860501

# FLAME PHOTOMETER STANDARD (K860501)

_Medical Specialties, Inc. · JLJ · Apr 7, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLJ/K860501

## Device Facts

- **Applicant:** Medical Specialties, Inc.
- **Product Code:** [JLJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLJ.md)
- **Decision Date:** Apr 7, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1315
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLJ/K860501](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLJ/K860501)

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